19004 Federal Register / Vol. 72, No. 72 / Monday, April 16, 2007 / Notices 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by April 25, 2007. 

Closed Committee Deliberations: On 

May 16, 2007 from 3:50 p.m. to 4:30 

p.m., the meeting will be closed to 

permit discussion where disclosure 

would constitute a clearly unwarranted 

invasion of personal privacy (5 U.S.C. 

552b(c)(6)). The committee will discuss 

the review of internal research programs 

in the Office of Bacterial Parasitic and 

Allergenic Products, Office of Vaccines 

Research and Review, CBER. 

Person’s attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Christine 

Walsh or Denise Royster at least 7 days 

in advance of the meeting. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: April 6, 2007. 

Randall W. Lutter, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E7–7090 Filed 4–13–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301/ 

496–7057; fax: 301/402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

New Mouse T Cell Receptors as 

Potential Therapeutic Agents for the 

Treatment of Metastatic Cancer 

Description of Technology: Adoptive 

immunotherapy is one of the most 

promising new therapeutic approaches 

to treat cancer. 

T cell receptors (TCR) are the proteins 

responsible for the T cell’s ability to 

recognize infected or transformed cells. 

A TCR consists of two domains, one 

variable domain that recognizes the 

antigen and one constant region that 

helps the TCR anchor to the membrane 

and transmit the recognition signal by 

interacting with other proteins. 

This invention describes the 

identification of two mouse TCRs that 

target a common and highly expressed 

melanoma antigen, gp100, expressed by 

human cancers. These TCRs, have 

superior (100–1000 times) biological 

function compared to other human 

tumor-specific TCR that are currently in 

use in experimental trials using 

genetically engineered T cells. 

Therefore, these new TCRs represent 

potential therapeutic agents that can be 

used in the treatment of metastatic 

cancers, especially melanomas. 

Applications: New mouse TCRs have 

been identified that recognize human 

gp100; The mouse TCRs have 100–1000 

times superior biological function 

compared to their human counterpart in 

recognizing gp100 when expressed in 

human lymphocytes; Human T cells 

genetically engineered to express new 

TCRs can serve as potential therapeutic 

agents in the treatment of patients with 

metastatic cancers; Clinical trials with 

these novel TCRs are currently being 

planned. 

Development Status: Pre-clinical work 

has been completed and clinical studies 

are forthcoming. 

Inventors: Nicholas P. Restifo et al. 

(NCI). 

Relevant Publications: 

1. A manuscript relating to this 

invention is under preparation and will 

be available once accepted. 

2. RA Morgan et al. Cancer regression 

in patients after transfer of genetically 

engineered lymphocytes. Science. 2006 

Oct 6;314(5796):126–129. 

Patent Status: U.S. Provisional 

Application No. 60/884,732 filed 12 Jan 

2007 (HHS Reference No. E–059–2007/ 

0–US–01); U.S. Provisional Application 

No. 60/885,724 filed 19 Jan 2007 (HHS 

Reference No. E–059–2007/1–US–01). 

Licensing Status: This technology is 

available for licensing under an 

exclusive or non-exclusive patent 

license. 

Licensing Contact: Michelle Booden, 

Ph.D.; 301/451–7337; 

boodenm@mail.nih.gov. 

Collaborative Research Opportunity: 

The Surgery Branch, NCI, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize this T cell receptor that 

is specific for human tumors. Please 

contact John D. Hewes, Ph.D. at 301–

435–3121 or hewesj@mail.nih.gov for 

more information. 

A Novel DNA Vaccine for the 

Treatment of Malignancies Expressing 

Immature Laminin Receptor Protein 

Description of Technology: This 

invention describes a new potent 

chemoattractant-based DNA vaccine to 

evoke therapeutic anti-tumor responses 

against tumors. The vaccine targets the 

antigen presenting cells (APCs) to 

efficiently present an antigen to MHC 

class I and class II molecules to induce 

tumor specific CD4 and CD8 T cell 

responses. 

The antigen tested is a highly 

conserved oncofetal antigen named 

immature laminin receptor protein 

(OFA–iLRP) that is preferentially 

expressed in malignant tissues. The 

vaccine construct consists of novel 

fusion proteins with enhanced binding 

affinities to augment antigen processing 

and antitumor responses. 

Applications and Modality: 

1. In vivo laboratory data shows that 

OFA–iLRP can be used as a potential 

immunotherapeutic antigen for the 

treatment of several malignancies 

including lymphoma, breast, lung, and 

ovarian. 

2. The vaccine construct is a novel 

fusion protein designed to enhance 

immunogenicity of OFA–iLRP via 

delivering it to chemokine receptors 

expressed on antigen presenting cells. 

3. The vaccine formulation will be 

most effective if used for treatment of 

cancer patients with minimal residual 

disease to protect from the disease 

relapse. 

4. The vaccine potentially could be 

effective as a preventive measure for 

people with cancer predisposition by 

eliciting long term anti-OFA–iLRP 

humoral and cellular memory. 

5. Very simple and less invasive 

vaccine that can be easily delivered to 

the skin, muscle or other tissues. 


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Federal Register / Vol. 72, No. 72 / Monday, April 16, 2007 / Notices 19005 

Market: Previous attempts to produce 

a vaccine construct with OFA–iLRP 

antigen have been laborious, expensive 

and non-reproducible showing no 

definitive demonstrations on the 

efficacy use of OFA–iLRP as a cancer 

vaccine. This simple chemoattractant 

based DNA vaccine is effective, 

potential cancer therapy with extensive 

in vivo data. It can be a valuable 

addition to the fast growing cancer 

vaccine market. 

Development Status: The technology 

is currently in the pre-clinical stage of 

development and planned for clinical 

tests in patients with NSCLC (tentative 

start date 2008). 

Inventors: Arya Biragyn et al. (NIA) 

Related Publications: 

1. A manuscript directly related to 

this technology will be available as soon 

as it is accepted for publication. 

2. A Biragyn et al. Genetic fusion of 

chemokines to a self tumor antigen 

induces protective, T-cell dependent 

antitumor immunity. Nat Biotechnol. 

1999 Mar;17(3):253–258. 

3. A Biragyn et al. Mediators of innate 

immunity that target immature, but not 

mature, dendritic cells induce antitumor 

immunity when genetically fused with 

nonimmunogenic tumor antigens. J 

Immunol. 2001 Dec 1;167(11):6644–

6653. 

Patent Status: U.S. Provisional 

Application No. 60/841,927 filed 01 Sep 

2006, entitled ‘‘Methods and 

Compositions for the Treatment and 

Prevention of Cancer’’ (HHS Reference 

No. E–271–2006/0–US–01). 

Licensing Status: Available for 

exclusive and non-exclusive licensing. 

Licensing Contact: Thomas P. Clouse, 

J.D.; 301/435–4076; 

clousetp@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute on Aging, 

Immunotherapeutics Unit, Laboratory of 

Immunology, is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize simple and potent 

vaccines that target embryonic antigens 

expressed in tumors. Please contact 

John D. Hewes, Ph.D. at (301) 435–3121 

or hewesj@mail.nih.gov for more 

information. 

Preparation of (R,R)-Fenoterol and 

(R,R)-or (R,S)-Fenoterol Analogues and 

Their Use in Treating Congestive Heart 

Failure 

Description of Technology: This 

technology is directed to the discovery 

of (R,R)- and (R,S,)-fenoterol analogues 

which are highly effective and selective 

at binding B2-adrenergic receptors. The 

patent application includes methods of 

using such compounds and 

compositions for the treatment of 

cardiac disorders such as congestive 

heart failure and pulmonary disorders 

such as asthma or chronic obstructive 

pulmonary disease. 

Market: Approximately 5 million 

individuals are diagnosed with 

congestive heart failure in the United 

States and an estimated 3.5 million 

hospitalizations are attributed to heart 

failure each year. 

Inventors: Irving W. Wainer et al. 

(NIA). 

Patent Status: U.S. Provisional 

Application No. 60/837,161 filed 10 

Aug 2006 (HHS Reference No. E–205–

2006/0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Fatima Sayyid, 

M.H.P.M.; 301/435–4521; 

sayyidf@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute on Aging, 

Laboratory of Clinical Investigation, is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize the 

use of fenoterol analogues in the 

treatment of cardiac disorders. Please 

contact John D. Hewes, Ph.D. at 301–

435–3121 or hewesj@mail.nih.gov for 

more information. 

Transgenic Mouse Model that has 

Defective Innate and Adaptive 

Immunity 

Description of Technology: The 

present research tool is a transgenic 

mouse model (C57BL/6 H–2b) that has 

defective innate and adaptive immunity. 

The mouse model harbors adaptive 

immunity cells, but lacks normal 

cellular responses and has an altered 

pattern of antibody production. The 

cells of the innate immune system (NK 

and NKT cells) are also nearly absent. 

The mouse model lacks lymph nodes. 

The mouse model also lacks the ability 

to reject autologous, allogeneic, and 

presumably xenogeneic cells. The 

mouse model also has a defective 

antibody production mechanism, 

making only early antibodies (IgM) and 

little, if any, mature isotypes (G2a, G2b). 

Applications and Modality: 

1. New mouse model to study human 

tumors. 

2. New mouse model to study 

immune function reconstitution. 

3. New mouse model to study the 

development of lymph nodes and role of 

lymph nodes in the disease process. 

4. Most mouse or human progenitor 

cells can be transferred to and engraft in 

the mouse model. 

Market: 

1. In 2006, 600,000 estimated deaths 

from cancer related diseases. 

2. Immunotherapy market is expected 

to double in the next 5 years. 

3. Research tool useful for adoptive 

immunotherapy studies. 

Development Status: The technology 

is a research tool. 

Inventor: John R. Ortaldo (NCI). 

Related Publications: 

1. JJ Subleski, VL Hall, TC Back, JR 

Ortaldo, RH Wiltrout. Enhanced 

antitumor response by divergent 

modulation of natural killer and natural 

killer T cells in the liver. Cancer Res. 

2006 Nov 15;66(22):11005–11012. 

2. JR Ortaldo, A Mason, J WilletteBrown, FW Ruscetti, J Wine, T Back, T 

Stull, EW Bere, L Feigenbaum, R 

Winkler-Pickett, and HA Young. 

Modulation of lymphocyte function 

with inhibitory CD2: Loss of NK and 

NKT function. Submitted to Blood (2/ 

2007). 

Patent Status: HHS Reference No. E–

290–2005/0—Research Tool. This 

technology is not patented. The mouse 

model will be transferred through a 

Material Transfer Agreement (for notfor-profit institutions) or through a 

Biological Materials License 

(commercial entities). 

Licensing Status: Available for nonexclusive licensing. 

Licensing Contact for Commercial 

Entities: Thomas P. Clouse; 301/435–

4076; clousetp@mail.nih.gov. 

Material Transfer Agreement Contact 

for Not-For-Profit Institutions: Kathy 

Higinbotham; 301/846–5465; 

higinbok@mail.nih.gov. 

Dissection Tools and Methods of Use 

Description of Technology: Available 

for licensing is a dissection tool for 

cutting cell aggregates into smaller 

portions for further colony propagation. 

It is comprised of a handle attached to 

a rotatable shaft fitted with a cutting 

blade. The technology describes a safe 

and practical device that provides 

maximum product yield by preventing 

material from accumulating between the 

cutting surfaces. It also provides for 

more uniform cut colonies using lesser 

number of cuts than existing stem cell 

cutting instruments. 

Applications: Makes possible the 

sectioning of cultured embryonic stem 

cells into smaller fractions for their 

transfer to new culture medium and 

subsequent incubation. 

Market: Researchers worldwide who 

utilize cultured embryonic stem cells. 

Inventors: Soojung Shin (NIA). 

Patent Status: U.S. Provisional 

Application No. 11/531,972 filed 14 Sep 

2006 (HHS Reference No. E–272–2005/ 

0–US–01). 


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19006 Federal Register / Vol. 72, No. 72 / Monday, April 16, 2007 / Notices 

Licensing Status: Available for nonexclusive licensing. 

Licensing Contact: Fatima Sayyid, 

M.H.P.M.; 301/435–4521; 

sayyidf@mail.nih.gov. 

Dated: April 9, 2007. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E7–7108 Filed 4–13–07; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel, SPORE in 

GI and Head & Neck Cancers. 

Date: June 11–12, 2007. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Shamala K. Srinivas, PhD, 

Scientific Review Administrator, Research 

Programs Review Branch, Division of 

Extramural Activities, National Cancer 

Institute, 6116 Executive Boulevard, Room 

8123, Bethesda, MD 20892, 301–594–1224, 

ss537t@nih.gov. 

Name of Committee: National Cancer 

Institute Initial Review Group, Subcommittee 

G—Education. 

Date: June 26–27, 2007. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Gaithersburg Marriott 

Washingtonian Center, 204 Boardwalk Place, 

Gaithersburg, MD 20878. 

Contact Person: Sonya Roberson, PhD, 

Scientific Review Administrator, Resources 

and Training Review Branch, Division of 

Extramural Activities, National Cancer 

Institute, 6116 Executive Blvd., Room 8109, 

Bethesda, MD 20892, 301–594–1182, 

robersos@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel, R25 

Special Emphasis Panel (SEP). 

Date: June 26, 2007. 

Time: 5 p.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Gaithersburg Marriott 

Washingtonian Center, 204 Boardwalk Place, 

Gaithersburg, MD 20878. 

Contact Person: Robert Bird, PhD, 

Scientific Review Administrator, Resources 

and Training Review Branch, Division of 

Extramural Activities, National Cancer 

Institute, 6116 Executive Boulevard, Room 

8113, Bethesda, MD 20892–8328, 301–496–

7978, birdr@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel, Cancer 

Prevention Research Small Grant Program 

(R03). 

Date: June 28–29, 2007. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Renaissance M Street Hotel, 1143 

New Hampshire Avenue, NW., Washington, 

DC 20037. 

Contact Person: Irina V. Gordienko, PhD, 

Scientific Review Administrator, Special 

Review and Logistics Branch, Division of 

Extramural Activities, National Cancer 

Institute, 6116 Executive Boulevard, Room 

7073, MS 2829, Bethesda, MD 20892, 301–

594–1566, gordienkoiv@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Initial Review Group, Subcommittee 

H—Clinical Groups. 

Date: July 9–10, 2007. 

Time: 1 p.m. to 11 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Holiday Inn Georgetown, 2101 

Wisconsin Avenue, NW., Mirage I & II, 

Washington, DC 20007. 

Contact Person: Timothy C. Meeker, MD, 

PhD, Scientific Review Administrator, 

Resources and Training Review Branch, 

Division of Extramural Activities, National 

Cancer Institute, 6116 Executive Boulevard, 

Room 8103, Bethesda, MD 20892, (301) 594–

1279, meekert@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: April 5, 2007. 

Anna Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–1848 Filed 4–13–07; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the National Cancer 

Institute Special Emphasis Panel, March 

5, 2007, 12 p.m. to March 5, 2007, 4 

p.m. National Institutes of Health, 6130 

Executive Boulevard, Rockville, MD 

20852 which was published in the 

Federal Register on January 11, 2007, 72 

FR1335. 

The meeting notice is changed to 

reflect the date change from March 5, 

2007 to April 13, 2007. The meeting is 

closed to the public. 

Dated: April 5, 2007. 

Anna Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–1849 Filed 4–13–07; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following meeting 

of the Sickle Cell Disease Advisory 

Committee. 

The meeting will be open to the 

public, with attendance limited to space 

available. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

Name of Committee: Sickle Cell Disease 

Advisory Committee. 

Date: June 4, 2007. 

Time: 8:30 a.m. to 4 p.m. 

Agenda: Discussion of Programs and 

Issues. 

Place: National Institutes of Health, 

Rockledge 6700, 6700A Rockledge Drive, 

Room 354, Bethesda, MD 20817. 

Contact Person: Robert B. Moore, PhD, 

Health Scientist Administrator, Blood 

Diseases Program, Division of Blood Disease 

and Resources, National Heart, Lung, and 

Blood Institute, NIH, 6701 Rockledge Drive, 

Room 10162, Bethesda, MD 20892, 301/435- 

0050. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 


cprice-sewell on PROD1PC66 with NOTICES